General questions about the informed consent process

What is Informed Consent?

The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116, and the documentation of informed consent must comply with 45 CFR 46.117.

Informed consent is a process that does not end with a signed document. It is a process by which persons are educated about your project so that they can make a truly voluntary decision to participate. Therefore, any conversation about the project and any documents used in the project must be presented in "lay language." To ensure that the reading level of the document is appropriate for the audience, please go to our readability guide .

The informed consent document serves as one mechanism to document an individual's consent.